Title 21

PART 801 SUBPART A

Subpart A - General Labeling Provisions

• 21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374.
• 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

21:8.0.1.1.2.1.1.1	SECTION 801.1	801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
21:8.0.1.1.2.1.1.2	SECTION 801.3	801.3 Definitions.
21:8.0.1.1.2.1.1.3	SECTION 801.4	801.4 Meaning of intended uses.
21:8.0.1.1.2.1.1.5	SECTION 801.5	801.5 Medical devices; adequate directions for use.
21:8.0.1.1.2.1.1.6	SECTION 801.6	801.6 Medical devices; misleading statements.
21:8.0.1.1.2.1.1.7	SECTION 801.15	801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
21:8.0.1.1.2.1.1.8	SECTION 801.16	801.16 Medical devices; Spanish-language version of certain required statements.
21:8.0.1.1.2.1.1.9	SECTION 801.18	801.18 Format of dates provided on a medical device label.

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